Ekofomural granules for the preparation of oral solution 3g, no. 1 pack .

Bacterial urinary tract infections of various localization caused by microorganisms sensitive to fosfomycin: acute uncomplicated urinary tract infections; asymptomatic bacteriuria; prevention of urinary tract infections after surgery and transurethral diagnostic tests.

EkofomuralЃ is used once on an empty stomach 2-3 hours before or after a meal, preferably before bedtime, having previously emptied the bladder: adults and children over 12 years old in a daily dose of 30 g; children from 5 to 12 lay down in a daily dose of 20 g. The contents of the package are dissolved in ? glasses of water

The course of treatment is 1 day.

For the prevention of urinary tract infections during surgical intervention, diagnostic procedures, the above dose is taken 2 times - 3 hours before the intervention and 24 hours after it.

active substance: fosfomycin trometamol (in terms of 100% substance) - 3.752 g / 5.629 g in terms of fosfomycin - 2.0 g / 3.0 g;

auxiliary substances: lactulose - 1,000 g / 1,500 g, sodium saccharinate - 0.010 g / 0.016 g, strawberry flavoring - 0.070 g / 0.070 g, maltitol - up to a weight of 6.0 g / up to a weight of 8.0 g.

Hypersensitivity to fosfomycin or other components of the drug severe renal failure (creatinine clearance <10 ml / min) children under 5 years of age sucrase / isomaltase deficiency fructose intolerance glucose-galactose malabsorption.

Trade name of the drug

EkofomuralЃ

International non-proprietary name

Fosfomycin

Dosage form

granules for preparation of oral solution

Composition for one package:

active substance: fosfomycin trometamol (in terms of 100% substance) - 3.752 g / 5.629 g in terms of fosfomycin - 2.0 g / 3.0 g;

auxiliary substances: lactulose - 1,000 g / 1,500 g, sodium saccharinate - 0.010 g / 0.016 g, strawberry flavoring - 0.070 g / 0.070 g, maltitol - up to a weight of 6.0 g / up to a weight of 8.0 g.

Description

A mixture of powder and granules from white to light yellow with a strawberry scent.

Pharmacotherapeutic group

Antibiotic

ATX code

J01XX01

Pharmacodynamics:

EkofomuralЃ (active substance: fosfomycin) is a broad-spectrum antibiotic derivative of phosphonic acid.

EcofomuralЃ, being a structural analogue of phosphoenol pyruvate, inactivates the enzyme N-acetyl-glucosamino-3-o-enolpyruvyl transferase irreversibly blocks the condensation of uridine diphosphate-N-acetyl-glucosamine with phosphoenol pyruvate inhibits the synthesis of UDP-N-acetylmuramic acid, as a result of which the formation of suppressive acid is suppressed peptidoglycan of the bacterial cell wall and, as a consequence, the death of the microbial cell occurs (bactericidal effect). Inactivation of the enzyme N-acetyl-glucosamino-3-o-enolpyruvyl transferase reduces the likelihood of cross-resistance to antibiotics with a similar mechanism of action and creates conditions for synergy (in vitro experiments revealed a synergistic effect with amoxicillin cephalexin pipemidic acid).

Invitro gram-positive (Staphylococcus saprophyticus Enterococcus faecalis) and gram-negative (Escherichia coli Klebsiella pneumonia Citrobacler spp. Enterobacter spp. Proteus mirabilis) microorganisms are sensitive to fosfomycin.

Invitro fosfomycin reduces the adhesion of a number of bacteria to the epithelium of the urinary tract.

Pharmacokinetics:

Suction :

Fosfomycin is rapidly absorbed from the gastrointestinal tract when taken orally. In the body, it dissociates into fosfomycin and trometamol. The latter does not have antibacterial properties. The bioavailability of a single oral dose of 30 g is 34 to 65%. The maximum plasma concentration (Cmax) is observed 2-25 hours (Tmax.) After oral administration and is 22-32 mg / l (Cmax.). The plasma half-life is 4 hours.

Distribution:

Fosfomycin does not bind to plasma proteins is not metabolized in the body and accumulates in the urine. When a single dose of 30 g is taken orally in the urine, a high concentration of the antibiotic (from 1053 to 4415 mg / l) is achieved by 99% bactericidal for most common causative agents of urinary tract infections. The minimum inhibitory concentration of fosfomycin for these pathogens is 128 mg / l and is maintained in urine for 24-48 hours, which implies a one-day course of treatment with a single injection of the drug.

Derivation:

90% of fosfomycin is excreted by the kidneys unchanged with the creation of high concentrations in the urine. About 10% of the taken dose of the drug is excreted by the intestines unchanged. In patients with moderately reduced renal function (creatinine clearance <80 ml / min), including age-related physiological decreases in renal function (elderly people), the half-life of fosfomycin is lengthened, but the concentration in urine remains at a therapeutic level.

Indications:

Bacterial urinary tract infections of various localization caused by microorganisms sensitive to fosfomycin: acute uncomplicated urinary tract infections; asymptomatic bacteriuria; prevention of urinary tract infections after surgery and transurethral diagnostic tests.

Contraindications:

Hypersensitivity to fosfomycin or other components of the drug severe renal failure (creatinine clearance <10 ml / min) children under 5 years of age sucrase / isomaltase deficiency fructose intolerance glucose-galactose malabsorption.

Pregnancy and lactation:

During pregnancy, use only if the intended benefit to the mother outweighs the potential risk to the fetus. When prescribing the drug during lactation, it is necessary to stop breastfeeding during therapy.

Method of administration and dosage:

EkofomuralЃ is used once on an empty stomach 2-3 hours before or after a meal, preferably before bedtime, having previously emptied the bladder: adults and children over 12 years old in a daily dose of 30 g; children from 5 to 12 lay down in a daily dose of 20 g. The contents of the package are dissolved in ? glasses of water

The course of treatment is 1 day.

For the prevention of urinary tract infections during surgical intervention, diagnostic procedures, the above dose is taken 2 times - 3 hours before the intervention and 24 hours after it.

Side effects:

Possible disorders of the gastrointestinal tract (nausea heartburn diarrhea) skin rash allergic reactions headache dizziness asthenia paresthesia (feeling of numbness of the skin 'creeping crawl') optic neuritis tachycardia decreased blood pressure skin itching bronchial asthma angioedema anaphylitis urticaria colitis abdominal pain increased activity of 'hepatic' transaminases vulvovaginitis thrombocytosis leukopenia.

Overdose:

Overdose symptoms are diarrhea vestibular syndrome hearing impairment 'metallic' taste and general taste disturbances. With persistent diarrhea, symptomatic treatment is prescribed.

In case of overdose, it is recommended to increase urine output by ingestion of fluid.

Interaction:

Simultaneous administration of antacids or preparations containing calcium salts with metoclopramide should be avoided, as this can lead to a decrease in the concentration of fosfomycin in serum and urine. Simultaneous administration with other drugs that increase the motility of the gastrointestinal tract can also lead to a decrease in the concentration of fosfomycin in serum and urine.

Special instructions:

Taking EkofomuralЃ with food leads to a slowdown in its absorption, and therefore it is recommended to take the drug 2-3 hours before or after a meal.

During or after treatment with fosfomycin, diarrhea may occur in this case, the diagnosis of pseudomembranous colitis should be excluded, which requires the appointment of appropriate treatment. The use of drugs that suppress intestinal motility is contraindicated.

Patients with diabetes mellitus should take into account that the drug contains maltitol. Insulin is necessary for the metabolism of maltitol, but because of its slow and poor absorption from the gastrointestinal tract, maltitol does not significantly affect the plasma glucose concentration, therefore, dose adjustment of hypoglycemic drugs is not required.

Due to the content of maltitol, EcofomuralЃ is not recommended for patients with hereditary fructose intolerance.

Impact on the ability to drive vehicles. Wed and fur .:

Patients should be warned about the possibility of dizziness development, and if dizziness occurs, they should refrain from performing these activities.

Release form / dosage:

Granules for preparation of oral solution 20 g and 30 g.

Packaging:

60 g (for a dosage of 20 g) and 80 g (for a dosage of 30 g) in disposable bags made of multilayer packaging material (polyethylene terephthalate-polypropylene-aluminum-polyethylene). 1 package, together with instructions for use, is placed in a cardboard box.

Storage conditions:

In a place protected from moisture and light at a temperature not exceeding 25 ? C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Vacation conditions

On prescription

Manufacturer

Joint Stock Company 'AVVA RUS' (JSC 'AVVA RUS'), 610044, Kirov region, Kirov, st. Luganskaya, 53a, Russia